BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15941196 · Received December 8, 2022

    Report

    Report Number
    3006630150-2022-06846
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    October 11, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700; MODEL: SC-2218-70; SERIAL: (B)(4); BATCH: 7071868 / 7071927.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447963 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 363869 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention